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Trial record 86 of 323 for:    diabetes [CONDITION] AND diet [TREATMENT] | Recruiting, Not yet recruiting, Available Studies

Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus (DiNA-D)

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ClinicalTrials.gov Identifier: NCT02459496
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : November 22, 2016
Sponsor:
Collaborators:
German Center for Diabetes Research
California Walnut Company
Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

Brief Summary:

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.

The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes NAFLD Obesity Dyslipoproteinaemia Hypertension Behavioral: dietary consulting and advise Not Applicable

Detailed Description:

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.

The researchers therefore investigate dietary strategies such as low-carb diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.

An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
Study Start Date : September 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: low-carb diet, followed by conventional DGE diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day)
Behavioral: dietary consulting and advise
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines

Active Comparator: very-low calory diet, followed by conventional diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx. 1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines
Behavioral: dietary consulting and advise
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines




Primary Outcome Measures :
  1. change in insulin secretion (glucagon stimulation test) [ Time Frame: 3 weeks, 1 year ]
    change in insulin secretion (glucagon stimulation test)

  2. change in hepatic fat content (MR-S) [ Time Frame: 3 weeks, 1 year ]
    change in hepatic fat content (MR-S)

  3. change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter [ Time Frame: 3 weeks, 1 year ]
    change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter

  4. change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter [ Time Frame: 3 weeks, 1 year ]
    change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter

  5. change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter [ Time Frame: 3 weeks, 1 year ]
    change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter


Secondary Outcome Measures :
  1. inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6) [ Time Frame: 3 weeks, 1 year ]
    inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level)

  2. change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds [ Time Frame: 3 weeks, 1 year ]
    peripheral neuropathy

  3. change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD) [ Time Frame: 3 weeks, 1 year ]
    autonomic neuropathy



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female subjects
  • 18-79 years old
  • type 2 diabetes

Exclusion Criteria:

  • renal insufficiency
  • anaemia
  • immunosuppression
  • previous symptomatic cancer diagnosis
  • acute cardiovascular disease (stroke, coronary syndrome)
  • pregnancy and lactation
  • severe psychiatric disorders
  • corticoid or other immunosuppressive therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459496


Contacts
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Contact: Stefan Kabisch, Dr. med. 030 450 514 ext 429 stefan.kabisch@dife.de
Contact: June Inderthal 033 200 88 2771 june.inderthal@dife.de

Locations
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Germany
German Institut for Human Nutrition; Department for Clinical Nutrition Not yet recruiting
Nuthetal, Brandenburg, Germany, 14458
Contact: Margrit Kemper, Dr. med.    033200 88 2775    margrit.kemper@dife.de   
Contact: Silke Hornemann    033200 88 2779    silke.hornemann@dife.de   
Sub-Investigator: Margrit Kemper, Dr. med.         
Sub-Investigator: Silke Hornemann         
Sub-Investigator: Christiana Gerbracht, Dr.         
German Institute for Human Nutrition, Department for Clinical Nutrition Recruiting
Berlin, Germany, 12203
Contact: Stefan Kabisch, Dr. med.    030 450 514 ext 429    stefan.kabisch@charite.de   
Contact: Ulrike Kaiser, M.sc.    030 450 514 ext 428    ulrike.kaiser@charite.de   
Sub-Investigator: Stefan Kabisch, Dr. med.         
Sub-Investigator: Ulrike Kaiser, M.sc.         
Sponsors and Collaborators
German Institute of Human Nutrition
German Center for Diabetes Research
California Walnut Company
Institute for Cereal Processing GmbH/Institut für Getreideverarbeitung (IGV)
Investigators
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Principal Investigator: Andreas F.H. Pfeiffer, Prof. Dr. med. German Institute of Human Nutrition

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Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Director of the Department for Clinical Nutrition, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT02459496     History of Changes
Other Study ID Numbers: DiNA-D
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders